Health Canada revises validation rules for eCTD format

May, 2019

As part of our continuous global regulatory updates and in case it did not catch your attention, please be reminded on ...

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FDA at DIA RSIDM 2019 – Presentations Highlights

February, 2019

As part of the DIA RSIDM conference in Bethesda, ML in February 2019, the following comprehensive list summarizes our ...

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Phlexglobal’s View on eCTD v4.0

October, 2018

eCTD has been around for nearly 20 years and we’ve seen how it has transformed the regulatory submission landscape. The ...

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Australian regional specification – eCTD Version 3.1

June, 2018

Australia is phasing out eCTD Specification version 3.0 on 30th June 2018. The Therapeutic Goods Administration (TGA) ...

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eCTD Health Canada – an Overview

November, 2017

eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format ...

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eCTD Brief: The Deep Dive into Electronic Submissions

November, 2017

The ICH Common Technical Document (CTD) provides a common format for marketing authorization submissions in all ICH ...

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FDA has published a new guidance on eCTD 4.0

October, 2017

Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of ...

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